Cetirizine Sandoz 10 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Cetirizine Sandoz 10 mg/ml oral drops solution EFG

Cetirizine dihydrochloride

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Cetirizine Sandoz is and what it is used for
2. What you need to know before taking Cetirizine Sandoz
3. How to take Cetirizine Sandoz
4. Possible side effects
5. How to store Cetirizine Sandoz
6. Contents of the pack and other information

1. What is Cetirizina Sandoz and what is it used for

The active substance in Cetirizina Sandoz is cetirizine dihydrochloride.

Cetirizina Sandoz is an antiallergic medicine.

Cetirizina Sandoz 10 mg/ml oral drops solution is indicated for adults and children from 2 years of age for:

• relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• relief of chronic urticaria.

2. What you need to know before taking Cetirizina Sandoz

Do not use Cetirizina Sandoz:

• if you have severe renal disease (severe renal insufficiency with creatinine clearance below 10 ml/min),
• if you are allergic to cetirizine dihydrochloride, to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine, or to piperazine derivatives (active substances closely related to other medicines).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cetirizina Sandoz.

If you are a patient with renal insufficiency, consult your doctor, who may determine that you need a lower dose. Your doctor will establish the new dose.

If you have difficulty urinating (such as spinal cord disorders, prostate or bladder problems), please consult your doctor.

If you are an epileptic patient or a patient at risk of seizures, consult your doctor.

No clinically significant interactions have been observed between alcohol (at a blood level of 0.5 per mille (g/l), equivalent to one glass of wine) and cetirizine used at the recommended dose. However, safety data are not available when higher doses of cetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid taking cetirizine with alcohol.

If you are scheduled to undergo allergy testing, consult your doctor about whether you should stop taking cetirizine a few days before the test. This medicine may affect the results of your allergy tests.

Use of Cetirizina Sandoz with other medicines

Inform your doctor or pharmacist if you are using or have recently used, or might need to use, any other medicines.

Taking Cetirizina Sandoz with food, drinks and alcohol

Food does not affect the absorption of cetirizine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of cetirizine should be avoided in pregnant women. Accidental use of this medicine in pregnant women does not produce any harmful effects on the fetus. However, the medicine should only be administered if necessary and after consultation with a doctor.

Cetirizine is excreted in breast milk. Therefore, you should not take cetirizine during breastfeeding unless advised by your doctor.

Driving and using machines

Clinical studies have not shown evidence that cetirizine causes impairment of attention, reduced reaction capacity, or impaired ability to drive at the recommended dose.

If you intend to drive, perform potentially hazardous activities, or operate machinery, you should not exceed the recommended dose. You should observe your response to the medicine. If you are a sensitive patient, you may find that the simultaneous use of alcohol or other central nervous system depressants may further impair your attention and reaction ability.

Cetirizina Sandoz contains propylene glycol

This medicine contains 125 mg of propylene glycol in each ml of solution.

Cetirizina Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml of solution; thus, it is essentially “sodium-free”.

3. How to take Cetirizine Sandoz

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor again.

Adults and adolescents from 12 years of age:

The recommended dose is 10 mg once daily, equivalent to 20 drops.

Use in children between 6 and 12 years of age:

The recommended dose is 5 mg twice daily, administered as 10 drops twice daily.

Use in children between 2 and 6 years of age:

The recommended dose is 2.5 mg twice daily, administered as 5 drops twice daily.

Patients with renal impairment:

Patients with moderate renal impairment are advised to take 5 mg (10 drops) once daily.

If you have severe renal disease, please contact your doctor or pharmacist, who can appropriately adjust the dose.

If your child has renal disease, please contact your doctor or pharmacist, who can adjust the dose according to your child's needs.

If you notice that the effect of cetirizine is too weak or too strong, consult your doctor.

Duration of treatment

The duration of treatment depends on the type, duration, and course of your symptoms and will be determined by your doctor.

If you take more Cetirizine Sandoz than you should

If you have taken more cetirizine than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at: 91 562 04 20, indicating the medicine and the amount taken.

After an overdose, the adverse effects described below may occur with increased intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, weakness, headache, pupillary dilation, tingling, irritation, sedation, somnolence, stupor, abnormally increased heart rate, tremor, and urinary retention.

If you forget to take Cetirizine Sandoz

Do not take a double dose to make up for forgotten doses.

If you stop taking Cetirizine Sandoz

In rare cases, pruritus (intense itching) and/or urticaria may reappear if you stop taking cetirizine.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects are rare or very rare, but you must stop taking the medicine and tell your doctor immediately if you notice any of them:

• Allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face or throat).

These reactions may begin soon after taking the medicine for the first time, or they may start later.

The frequency of the possible adverse effects listed below is defined as follows:

Frequent adverse effects (may affect up to 1 in 10 people)

• Somnolence (drowsiness).
• Dizziness, headache.
• Pharyngitis, rhinitis (in children).
• Diarrhea, nausea, dry mouth.
• Fatigue.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Agitation.
• Paresthesia (abnormal skin sensations).
• Abdominal pain.
• Pruritus (itching), rash.
• Asthenia (extreme fatigue), malaise.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Allergic reactions, some severe (very rare).
• Depression, hallucination, aggression, confusion, insomnia.
• Seizures.
• Tachycardia (heart beating too fast).
• Abnormal liver function.
• Urticaria (hives).
• Edema (swelling).
• Weight gain.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Thrombocytopenia (low platelet levels in blood).
• Tics (spasms).
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contractions), tremor, dysgeusia (taste disturbance).
• Blurred vision, accommodation disorders (difficulty focusing vision), ocular nystagmus (eyes have uncontrolled circular movements).
• Angioedema (severe allergic reaction causing swelling of the face or throat), drug-induced rash.
• Difficulty or lack of control when urinating (bedwetting, pain and/or difficulty urinating).

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Increased appetite.
• Suicidal thoughts (recurring thoughts or obsession about suicide), nightmares.
• Amnesia, memory impairment.
• Vertigo (sensation of spinning or movement).
• Urinary retention (inability to completely empty the urinary bladder).
• Pruritus (intense itching) and/or urticaria after discontinuation of treatment.
• Joint pain.
• Blistering rash with pus.
• Hepatitis (inflammation of the liver).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetirizine Sandoz

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Storage conditions after first opening of the container: 12 months at room temperature.

Do not use this medicine after the expiry date stated on the packaging and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cetirizine Sandoz

• The active substance in Cetirizine Sandoz is cetirizine dihydrochloride. One ml (equivalent to 20 drops) contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride. The other components are: glycerol (E422), propylene glycol (E-1520), sodium acetate trihydrate and purified water.

Nature of the product and contents of the container

Cetirizine Sandoz is presented as a clear, colourless liquid, free from undissolved particles as observed visually.

Pack containing a 20 ml bottle of solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte Edificio Roble,

C/Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto Von Guericke Allee 1.

Barleben 39179

Germany

Date of the most recent revision of this leaflet: January 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/